Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

NCT03633682 | Completed

• 1 other identifier: STU00206204
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Depression and Anxiety at Week 2 and Week 4

  Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).

  Baseline, Week 2, Week 4

• Change in Anxiety at Week 2 and Week 4

  Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day).

  Baseline, Week 2, Week 4

Secondary Outcomes (2)

• App Usage

  Week 1, Week 2, Week 3, Week 4

• App Satisfaction

  Week 1, Week 2, Week 3, Week 4

Other Outcomes (7)

• Change in Mindfulness at Week 4

  Baseline and Week 4

• Change in Psychological Flexibility at Week 2 and Week 4

  Baseline, Week 2, Week 4

• Change in Depression, Anxiety, and Stress at Week 1, 2, 3, and 4

  Baseline, Week 1, Week 2, Week 3, Week 4

Study Arms (2)

Engagement Support

EXPERIMENTAL

In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages.

Behavioral: Headspace - Meditation and Mindfulness App; Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App

No Engagement Support

OTHER

Participants in this group will receive no text message support.

Behavioral: Headspace - Meditation and Mindfulness App; Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App

Interventions

Headspace - Meditation and Mindfulness App BEHAVIORAL

Participants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Engagement Support; No Engagement Support

Stop, Breathe, & Think - Meditation and Mindfulness App BEHAVIORAL

Participants randomized to this arm will receive 1-month full access to the Stop, Breathe, \& Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Engagement Support; No Engagement Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meet criteria for clinically significant distress caused by anxiety defined by a Generalized Anxiety Disorder-7 (GAD-7) greater than a 10 or clinically significant distress caused my depression defined by a Patient Health Questionnaire (PHQ-9) greater than 10
• years of age or older;
• fluent in English;
• lives in the Chicago area and are able to attend and in person session;
• own an internet ready smartphone with data and text plans.

You may not qualify if:

• have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures;
• past or current diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance or alcohol abuse dependence, or other diagnosis for which participation in the trial would be dangerous;
• suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9);
• adults unable to consent.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwester University, Feinberg School of Medicine, Center for Behavioral Intervention Technologies

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 16, 2018
• Study Start: June 26, 2018
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)